VOYDEYA® is contraindicated in patients with unresolved Neisseria meningitidis infection at treatment initiation and in patients who are not currently vaccinated against Neisseria meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.1
For further information visit our dedicated Dosing and Administration page below.
For further information visit our dedicated Dosing and Administration page below.
Dosing and Administration of Voydeya®
A subset of patients treated with a C5 inhibitor may experience residual anemia due to extravascular hemolysis (page 4)*.1,4-6
EVH is not considered life-threatening, and only clinically significant EVH* requires treatment.5,7
EVH is not considered life-threatening, and only clinically significant EVH* requires treatment.5,7
While clinically significant EVH is not defined by specific laboratory thresholds, the inclusion criteria in the VOYDEYA® Phase 3 ALPHA trial defined low haemoglobin as ≤9.5 g/dL and increased absolute reticulocyte count as ≥120×109/L, with or without transfusion support.1,4
VOYDEYA® when used with ULTOMIRIS® or SOLIRIS® helps the subset of patients with a confirmed treatment response (LDH <1.5× ULN) to a C5 inhibitor who experience residual haemolytic anaemia* due to EVH by:1,2,4,8
For more details, please visit our dedicated Mode of Action page below.
Mode of Action of VOYDEYA®
VOYDEYA® was studied in a randomised, placebo-controlled superiority Phase 3, clinical trial.4 An open-label long-term extension study which monitored patients receiving VOYDEYA® for up to 2 years.4 More information on how VOYDEYA® was studied can be found below.
VOYDEYA® Study Design
Add-on VOYDEYA® has shown clinically meaningful improvements in haemoglobin and fatigue at 12 weeks, with improvements maintained out to 72 weeks, respectively.1,4,9 Additionally, fewer patients needed transfusions over 72 weeks.1,9 Detailed information on the efficacy of Voydeya® is available below..
Efficacy of VOYDEYA®
VOYDEYA® was well-tolerated in a Phase 3 clinical trial and long term follow up of 72 weeks.1,4,9 Further details about the safety of Voydeya® can be accessed on the page below.
Safety of VOYDEYA®
VOYDEYA® helps patients to do more of the activities they want by addressing EVH – increasing haemoglobin levels, reducing the need for transfusion and decreasing fatigue.1,4
*The terms “clinically significant EVH” used in the VOYDEYA®1, ALPHA trial4 and “residual haemolytic anaemia” used in the SmPC refer to the same patient population. For simplicity, the term EVH will be used interchangeably throughout this document for both of the above terms. EVH in PNH is a mechanistic effect of complete terminal complement inhibition. Only EVH deemed clinically significant needs to be treated.5,9 There may be multiple causes of residual anaemia in PNH, to confirm whether residual anaemia is due to EVH, other causes should be eliminated.5,10,11
†VOYDEYA® may also be taken with SOLIRIS®.1
Adverse Event Reporting
Please report any adverse events via your national reporting system. Adverse events can also be reported to Alexion,AstraZeneca Rare Disease by contacting: https://contactazmedical.astrazeneca.com/
C5, complement component 5; CI, confidence interval; cs, clinically significant; EVH, extravascular haemolysis; IVH, intravascular haemolysis; LDH, lactate dehydrogenase; LSM, least squares mean; MMRM, mixed-effect model for repeated measures; PNH, paroxysmal nocturnal haemoglobinuria; SE, standard error; SMPC, summary of product characteristics; ULN, upper limit of normal.
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